Revisions to the Annual Signatory Institution Worksheet

CIRB STAKEHOLDERS,
 

The CIRB’s Annual Signatory Institution Worksheet and Quickguide have been revised to reflect changes to the following questions:

• Questions 4 and 5 – Clarified text regarding State and Local Laws
• Questions 7, 8, and 9 - Adding a field for Person Title
• Questions 8a – 8e – Clarified questions regarding Local Oversight
• Question 9 – Added or revised questions regarding notification, investigation, and reporting of potential unanticipated problems and/or serious or continuing noncompliance
• Question 10 – Clarified text regarding Financial Conflict of Interest
• Questions 11, 11a, 12, and 12a – Updated question text regarding institutional policies and guidelines that govern the informed consent document
• Question 14 and 14a – Updated question text regarding how assent and age of majority are documented (formerly Question 20)

 
These changes may require additional information to supplement what was provided in the previously approved submission.
 
If you have any question or comments, please contact the NCI CIRB Helpdesk.